Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome

Официальное название

Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

Обзор

This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients: * Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

Подробное описание

Primary objective of the studies:

* Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study); * Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic trématent or local ophthalmological treatment without IV chemotherapy; this is a minimally invasive interventional study).

Вмешательства

• Препарат Melphalan or Melphalan + Topotecan
  IAC: 2-6 cycles every 1 month (number based on the local tumor evolution), performed using radio-guided catheterization and delivery at the ostium of the ophthalmic artery, in neuroradiology operating room, and under General Anesthesia (GA). IAC will be administered at the Fondation Rothschild Hospital in collaboration with the Interventional Neuroradiology team.
• Препарат etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy
  2 to 6 cycles of combined etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy : thermotherapy and/or cryotherapy and/or iodine-125 plaques and/or intravitreal chemotherapy injections
• Препарат Carboplatin administered on Day 1
  Chemothermotherapy : Intravenous injection by carboplatin
• Устройство Thermotherapy (local treatment)
  Thermotherapy after carboplatin administered on Day 1
• Устройство Cryotherapy (local treatment)
  Cryotherapy (local treatment)
• Устройство Iodine-125 plaques (local treatment)
  Iodine-125 plaques (local treatment)
• Препарат Intravitreal Melphalan chemotherapy injections (local treatment)
  Intravitreal Melphalan chemotherapy injections (local treatment)

Первичные конечные точки

• Study 1: Rate of eye preservation [Срок оценки: 24 months after randomization]
• Visual function [Срок оценки: when patient is 6 years old and at least 24 months of follow-up after study inclusion]

Вторичные конечные точки (7)

• Ocular toxicity [Срок оценки: Up to 24 months after inclusion in the study]
• Systemic toxicity [Срок оценки: Up to 24 months after inclusion in the study]
• Relapse [Срок оценки: within 24 months after inclusion]
• Second malignant tumor [Срок оценки: 24 months after study inclusion]
• Additional assessment of visual function [Срок оценки: In the year patients turn 6 years of age and at least 24 months of treatment]
• Retinal assessment [Срок оценки: In the year patients turn 6 years of age and at least 24 months of treatment]
• Integration at school [Срок оценки: In the year patients turn 6 years of age and at least 24 months of treatment]

Критерии участия

Критерии включения

Overall study inclusion criteria:

• Newly diagnosed retinoblastoma (RB).
• Retinoblastoma with at least one eye eligible for conservative management.
• Patients likely to be compliant with the study requirements and visits, including late follow-up.
• Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
• Patients with no contraindication to the proposed treatments.
• Informed consent signed by parents or legal representative.
• French Social Security System coverage.

Study 1 inclusion criteria:

8.1. Children aged from 6 months to 6 years. 9. Retinoblastoma in at least one eye, deemed manageable with IAC in one side and without IV chemotherapy:

• Unilateral Retinoblastoma classified as group B, C (if vitreous seeds < 3 mm), D or E with no invasion of the anterior segment, and without massive tumor of more than 2/3 of the eye, eligible for conservative management, or
• Bilateral Retinoblastoma but with very unbalanced lesions between the two eyes: one eye group D or E without invasion of the anterior segment or massive tumor of more than 2/3 of the eye, eligible for IAC, and the other eye eligible for local treatment only (without IAC).

Study 2 inclusion criteria:

8.2. Retinoblastoma eligible for conservative management although not manageable with IAC:

• Unilateral Retinoblastoma in children below 6 months of age, classified as Group A, B, C or D, with or without vitreous seeding, compatible with conservative management, or
• Bilateral Retinoblastoma classified as group A, B, C D, or E without invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye and eligible for conservative management.

Критерии исключения

Overall study non-inclusion criteria:

• RB not eligible for conservative management :

• Extra-ocular extension of the disease, or
• Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye.
• Patient older than 6 years of age.
• Patients with another associated disease contra indicating systemic chemotherapy.
• Previously treated retinoblastoma by chemotherapy.
• Patients already treated for another malignant disease.
• Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Patients whose parents have not accepted the treatment regimen after explanation of it.
• Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs.
• Inclusion in another experimental anti-cancer drug therapy.

Study 1 non-inclusion criteria:

• Any contraindication or concomitant disease that would preclude the Study 1 treatment procedure and could delay treatment.

These patients should be eligible for Study 2.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 28 центров

• La Reunion - Chr Felix Guyon — Saint-Denis
• Amiens Chu — Amiens
• Angers Chu — Angers
• BESANCON CHU Hopital Jean Minjoz — Besançon
• Bordeaux Chu — Bordeaux
• BREST CHRU Hopital Morvan — Brest
• CAEN CHU — Caen
• CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP) — Clermont-Ferrand
• … и ещё 20 центров

Идентификаторы

NCT: NCT04681417 · IC 2019-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗